U.S. patent number 7,422,576 [Application Number 10/320,211] was granted by the patent office on 2008-09-09 for localized liquid therapy and thermotherapy device.
This patent grant is currently assigned to KCI Licensing, Inc.. Invention is credited to Thomas A. Boynton, Royce Johnson.
United States Patent |
7,422,576 |
Boynton , et al. |
September 9, 2008 |
Localized liquid therapy and thermotherapy device
Abstract
A device for directly applying thermotherapeutic liquid to an
area upon the surface of an afflicted patient, and methods of use
thereof, are described. In particular a device for applying
water-based liquid at a therapeutic temperature directly to an
afflicted area in order to create a localized hyperthermia, is
presented. The afflicted area may be either on the skin of the
patient, or subcutaneous. The device is also effective for
disinfection, irrigation, lavage, and the like, when employing a
suitable solution. The liquid may also have a mild oxidizing
effect, which, if greater upon afflicted than upon non-afflicted
cells, would enhance the therapeutic effect in conjunction with the
therapy herein described.
Inventors: |
Boynton; Thomas A.
(Floresville, TX), Johnson; Royce (Universal City, TX) |
Assignee: |
KCI Licensing, Inc. (San
Antonio, TX)
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Family
ID: |
24361823 |
Appl.
No.: |
10/320,211 |
Filed: |
December 16, 2002 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20030225441 A1 |
Dec 4, 2003 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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09590333 |
Jun 8, 2000 |
6520982 |
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Current U.S.
Class: |
604/291; 602/41;
607/104 |
Current CPC
Class: |
A61F
7/00 (20130101); A61B 90/80 (20160201); A61F
2007/0069 (20130101) |
Current International
Class: |
A61F
7/00 (20060101); A61F 7/02 (20060101) |
Field of
Search: |
;607/96,98,99,104,108,109-112 ;601/159-162 ;604/319-323,304-305,291
;602/41-48 |
References Cited
[Referenced By]
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Primary Examiner: Gibson; Roy D
Parent Case Text
RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No.
09/590,333, filed Jun. 8, 2000 now U.S. Pat. No. 6,520,982. By this
reference, the full disclosure of U.S. application Ser. No.
09/590,333 is incorporated herein as though fully set forth in
their respective entirety.
Claims
We claim:
1. A device for applying therapeutic liquid to an afflicted area of
a surface of an afflicted patient's body, comprising: a supply
means for supplying a therapeutic liquid; a return means for
returning liquid; a control means for thermally regulating the
therapeutic liquid; a negative pressure pump operatively coupled to
said return means; an applicator interposed between said supply
means and said return means, said applicator being adapted to be
secured about said afflicted area; wherein the applicator comprises
a dressing material for placement on the afflicted area and a
dressing adhesive covering; and wherein the negative pressure pump
is fluidly connected to the supply means such that liquid is
returned to the supply means after being drawn through the
applicator.
2. The device according to claim 1 further comprising a reservoir
for storing said therapeutic liquid.
3. The device according to claim 1, wherein the liquid is heated
prior to application to the afflicted area.
4. The device according to claim 3, wherein heated liquid induces a
localized hyperthermia in the afflicted area after application of
the heated liquid to the afflicted area.
5. The device according to claim 1, wherein the liquid is cooled
prior to application to the afflicted area.
6. The device according to claim 5, wherein the cooled liquid
induces a localized hypothermia in the afflicted area after
application of the cooled liquid to the afflicted area.
7. The device according to claim 1, wherein negative pressure
generated by the negative pressure pump underneath the dressing
adhesive covering functions to drain the afflicted-area, to secure
the dressing material against the afflicted area, and to provide
negative pressure wound therapy to the afflicted area.
8. The apparatus of claim 1, wherein the applicator further
comprises a porous pad.
9. An apparatus for applying therapeutic liquid, the apparatus
comprising: a reservoir; a controller operably connected to the
reservoir to regulate a temperature of liquid stored in the
reservoir; an applicator fluidly connected to the reservoir; a
negative pressure pump fluidly connected to the applicator to draw
liquid from the reservoir through the applicator; wherein the
applicator further comprises a dressing and an adhesive covering;
and wherein the negative pressure pump is fluidly connected to the
reservoir such that liquid is returned to the reservoir after being
drawn through the applicator.
10. The apparatus of claim 9, further comprising a liquid heater
exposed to liquid and operably connected to the controller, wherein
the controller is operable to regulate power to the liquid heater
so that liquid is heated.
11. The apparatus according to claim 10, wherein: the applicator is
adapted to be positioned about an afflicted area; and the heated
liquid induces a localized hyperthermia in the afflicted area after
application of the heated liquid to the afflicted area.
12. The apparatus of claim 9, wherein the applicator further
comprises a porous pad.
13. The apparatus of claim 9, wherein: the applicator is adapted to
be positioned about an afflicted area; and the liquid is cooled
prior to application to the afflicted area.
14. An apparatus for applying therapeutic liquid, the apparatus
comprising: a reservoir; an applicator; a supply line fluidly
connected to the reservoir and the applicator; a negative pressure
pump; a return line fluidly connected to the applicator and the
negative pressure pump; a set-point controller operably coupled to
the reservoir to regulate a temperature of therapeutic liquid
stored in the reservoir; wherein the negative pressure pump is
operable to draw liquid from the reservoir through the applicator;
wherein the applicator further comprises a dressing and an adhesive
covering; and wherein the negative pressure pump is fluidly
connected to the reservoir such that liquid is returned to the
reservoir after being drawn through the applicator.
15. The apparatus of claim 14, further comprising a liquid heater
exposed to liquid and operably connected to the set-point
controller, wherein the set-point controller is operable to
regulate power to the liquid heater so that liquid is heated.
16. An apparatus for applying therapeutic liquid, the apparatus
comprising: a reservoir; an applicator; a supply line fluidly
connected to the reservoir and the applicator; a negative pressure
pump; a return line fluidly connected to the applicator and the
negative pressure pump; a set-point controller operably coupled to
the reservoir to regulate a temperature of therapeutic liquid
stored in the reservoir; wherein the negative pressure pump is
operable to draw liquid from the reservoir through the applicator;
wherein the applicator comprises a top surface, a wall surface, an
open bottom, and a receptor; and wherein the supply line is coupled
to the receptor.
17. The apparatus of claim 16, wherein the negative pressure pump
is fluidly connected to the reservoir such that liquid is returned
to the reservoir after being drawn through the applicator.
18. The apparatus of claim 16, further comprising a liquid heater
exposed to liquid and operably connected to the set-point
controller, wherein the set-point controller is operable to
regulate power to the liquid heater so that liquid is heated.
19. A method of creating localized therapeutic hyperthermia, the
method comprising: applying heat to a liquid; placing an applicator
over an afflicted area; applying a negative pressure to the
applicator to provide an engagement between the applicator and the
afflicted area and to draw the liquid through the applicator; and
recirculating the liquid through the applicator after the liquid
has been drawn through the applicator; and wherein the applicator
includes a dressing and an adhesive covering.
20. The method of claim 19, further comprising: measuring a
temperature of the liquid; and adjusting the heat applied to the
liquid to maintain the liquid at a therapeutically beneficial
temperature.
Description
FIELD OF THE INVENTION
This invention relates generally to devices for applying localized
liquid therapy and/or thermotherapy to an afflicted area of a
patient. More particularly, this invention relates to a device, and
method of use thereof, which directly applies a liquid, most
usually a water based liquid to a selected area to create the
desired therapeutic effect, most usually a localized hyperthermia,
which is effective in treating localized afflictions, such as
moles, lesions, tumors, malignancies, both surface and
subcutaneous, and the like, or a therapeutic lavage or
irrigation.
BACKGROUND OF THE INVENTION
Heat and cold have both been used to effectively treat afflicted
patients. Directly applying liquid to afflicted cells is also well
known. Cold has often been used as a localized treatment, while
heat has been, and is currently used as both a localized and total
body treatment. Using heat to treat a localized afflicted area of
an afflicted patient is most relevant to the present invention.
The search continues for ways to effectively treat wounds, tumors
and similar disorders while minimizing adverse collateral effects.
For example, assignee has been a leader in treating open wounds
through a process known as Vacuum Assisted Closure.TM.,
("V.A.C..RTM."). In a similar vein, localized thermotherapy,
primarily localized hyperthermia, has also shown promise as a
treatment modality which is capable of producing beneficial
therapeutic effects without significant adverse collateral effects
for certain conditions. However, the localized hyperthermic
treatment modalities in the prior art, all suffer from serious
drawbacks, limitations, or side effects.
Research has demonstrated that heating cancerous, or other abnormal
cells to over about 42.degree. Celsius ("C.") can kill the abnormal
cells, while causing little damage to the surrounding normal cells.
This treatment is temperature sensitive. Heating the cancer cells,
for example, to a temperature between nominal body temperature,
37.degree. C. and approximately 41.degree. C. or greater can
seriously damage them. To maximize patient safety, this
hyperthermia treatment must be localized.
The variety of available heat transfer methods for localized
thermotherapy is limited. Heat is transferred in three ways,
radiation, convection, or conduction. The heat transfer medium
creating the localized hyperthermia can be either heated in situ or
be heated exogenously, before being placed upon the patient. The
medium can either be placed in direct contact with the afflicted
cells or, transfer heat to the afflicted cells through an
intermediary.
Localized hyperthermia therapy is presently used in treating
prostate afflictions, breast cancer, and other afflictions. This
modality involves placing implants about the afflicted patient's
afflicted cells, and then heating the implants by radiating EMF or
ultrasonic energy thereto. The heat from the implants then migrates
into the afflicted tissue, via conduction, thereby raising the
temperature of the afflicted cells. Several issued patents
demonstrate variations of this technique. Issues relating to
possible adverse affects of exposure to both radiation, and
radiated energy abound. However, as most sufferers of prostate
cancer are older men who are past the age of fathering children,
and female breasts are relatively remote from the female
reproductive organs, the possible long-term adverse collateral
effects of using such radiant energy treatments are minimized.
Applicant has discovered various patents that employ and exemplify
other energy transfer methods and media in creating localized
hyperthermias. The first of these patents, Guibert, U.S. Pat. No.
4,595,008, issued Jun. 17, 1986, may be summarized as follows:
" . . . air heated to a temperature well above normal body
temperature is projected as a high velocity stream in a pulsatory
wave pattern toward a localized skin area overlying a problem
region, thereby subjecting this area to high-velocity heated air
pulses separated by lower air temperature, relatively static
intervals.
"The pulsatory wave pattern is created by apparatus, which operates
in a periodic interruption mode, in a cyclical stepping mode or in
a cyclical sweeping mode, depending on the nature of the instrument
and its intended applications.
"As a consequence of the pulsatory wave pattern, heat transfer
takes place through the body tissue toward the problem region
during the intervals between the pulses, this inward transfer
acting to reduce the temperature at the skin surface to a degree
preventing an undue rise thereof. While during the pulse periods
the temperature of the hot air at the skin surface is much higher
than body temperature, the duration of each pulse is relatively
short and insufficient to cause discomfort or injury to the
patient." Guibert Col. 2 line 61-Col. 3 line 15.
This description shows that Guibert uses a heated fluid to
indirectly transfer heat to an afflicted area of a patient; the
fluid, air, does not come into contact with the afflicted area.
Another device that also uses a heated fluid to treat an afflicted
portion of a patient's body is Shantha, U.S. Pat. No. 5,195,965
issued Mar. 23, 1993. Shantha may be summarized as follows:
" . . . the present invention comprises an apparatus for heating
the interior surfaces of a hollow organ or orifice, for example the
interior surfaces of the reproductive tract of a female human
being, for the treatment of viral infections and cancers. For
example, the invention is useful for the treatment of Human
Papilloma Virus, chlamydia, trichomonas vaginitis, vaginal yeast
infections, gonococcus, rectal and anal infections, rectal and anal
cancers, esophageal cancer, etc. The apparatus comprises an
insertion body having a flexible outer surface and is adapted for
insertion into the hollow organ or orifice, such as the female
reproductive tract. The insertion body is adapted to contact and
conform to the interior surfaces of the hollow organ. The apparatus
also includes means for heating the outer surface of the insertion
body and for maintaining a selected temperature at the outer
surface.
"Preferably, the insertion body comprises an inflatable outer
membrane or balloon supported about a semi-rigid support member.
The inflatable balloon is adapted to contain liquid under pressure
and the apparatus includes means for circulating liquid between the
inflatable balloon and an external heating device. Sensor means are
positioned along the outer surface of the inflatable balloon for
determining the temperature of the outer surface of the balloon.
Control means, responsive to the temperature of the outer surface
as determined by the sensor means, are provided for controlling the
external heating device so as to maintain the temperature of the
outer surface at the selected temperature.
"With this construction, the inflatable balloon can be inserted
into the hollow organ in an uninflated state and subsequently
inflated with liquid under pressure. The liquid is then circulated
and heated in the external heating device. The liquid, preferably
water, is maintained at a temperature of between 40.degree. C. and
44.degree. C. for between 2 and 6 hours. Preferably, the water is
maintained at a temperature of 41.8.degree. C. (roughly
107.2.degree. F.), and the inflatable body is maintained in the
hollow organ for four (4) hours kills many bacteria, viruses and
cancer cells. The immune system of the patient normally is
stimulated by the destroyed virus cells, microbes, and cancer cells
and attacks any infected or cancerous cells not destroyed by the
heat. This temperature of 41.8 degree C. is low enough that healthy
tissues survives relatively undamaged, owing to the lesser heat
sensitivity of healthy cells as compared with infected and
cancerous cells. The localized nature of the treatment, together
with the relatively low temperature involved, ensures that the risk
of death to the patient from an elevated body temperature is
substantially zero. The rather low temperatures involved also
protect the patient from much pain and discomfort during
treatment." Shantha Col. 2., line 36-Col. 3, line 22.
Various other heated liquid devices and methods of treating hollow
organs or body orifices exist, and operate in the same basic
manner. However, there is a need for a system and method for the
creation of a localized therapeutic hyperthermia by means of a
heated liquid directly contacting afflicted cells for a period of
significant duration. More particularly there is a need for a
device, or method of treatment, which involves, selecting a
therapeutic liquid, heating the selected liquid through conduction
so as to avoid EMF or ultrasonic radiation, placing a therapeutic
applicator about the afflicted cells, and circulating the heated
fluid through the therapeutic applicator, thereby creating a
localized hyperthermia in the afflicted cells within the
circumference of the applicator. Furthermore it would be beneficial
to provide the use of a localized hyperthermic modality in
conjunction with Vacuum Assisted Closure.TM., ("V.A.C..RTM.") of
open wounds. It is towards the fulfillment of these needs that the
present invention is directed.
SUMMARY
The present invention is a novel device used to create a localized
therapeutic effect on afflicted cells on an afflicted patient.
These effects include cleaning, disinfecting, cooling, heating, and
methods of use thereof. The device embodying the present invention
comprises a therapeutic liquid, liquid supply means, liquid
energizing means, circulating means, and control means. The device
may also be used in conjunction with V.A.C..RTM. therapy. These
elements interact, and are employed, as briefly described
below.
An appropriate therapeutic liquid is selected. Most often this
liquid will be water, or a liquid comprising at least 90% water on
a weight/weight ("w/w %") basis. Thermal energy is directly applied
to, or taken from, the liquid. Most commonly the liquid will be
heated. This energy transfer is regulated by the control means,
which compares the actual liquid temperature with a selected
reference temperature. The heated or cooled liquid is then used to
create a local therapeutic effect. Control means also comprises
system control means that monitors and regulates the overall
operation of the device.
The balance of this description presumes that the liquid is heated
rather than cooled. The liquid will either be recirculated if a
closed loop embodiment is selected, or be used once and discarded
if an open loop embodiment is selected. An afflicted area, such as
a mole, skin cancer, or the like, is located on the afflicted
patient. The afflicted area may be on the skin, or
subcutaneous.
The circulation means comprises supply means, recovery means, and
applicator means. The applicator has an open bottom or bottom
portion and is placed about the afflicted cells on the skin of the
patient, and most likely, some of the surrounding non-afflicted
cells on the patent's skin as well. Before commencing the
application of the therapeutic liquid, a fluid tight seal must be
established between the patient and the application means; this
seal must be maintained for at least the duration of the liquid
application. The applicator may also comprise a fluid tight
V.A.C..RTM. dressing. The liquid flows from the liquid supply
means, into the supply conduit of the circulation means, into the
applicator means, and then into the return conduit. The liquid is
then either recirculated, or discarded.
Circulation means also likely comprises liquid pressurization means
that likely comprise a pump; though a sealed pressurized embodiment
is also contemplated. Alternatively, gravity flow, or the negative
pressure associated with V.A.C..RTM., roughly 150 mm Hg, in an open
loop system could be considered. In a preferred embodiment, the
pump is placed on the return side of the circulation means. This
configuration has the advantage of applying negative pressure to
the application means thereby creating a self actuated negative
pressure seal between the application means and the patient's skin
for the duration of therapeutic liquid application. Alternatively a
sealing mechanism could be used to maintain the necessary seal
between the application means and the afflicted patient. Applying
pressure to the liquid also creates a more rapid circulation of the
liquid to the epidermal region, which could have beneficial
therapeutic effects.
Accordingly an object of the present invention is to provide a
device that employs an exogenously heated fluid to provide direct
thermotherapy to an afflicted potion of a patient.
Another object of the present invention is to provide localized
thermal therapy where the perimeter of the afflicted portion of the
patient is within the boundaries of the therapy applicator of the
present invention.
A further object of the present invention is to provide a novel
device that provides ravage to an afflicted patient.
Yet another object of the present invention is to combine the
therapeutic effects of the present invention with the positive
effects associated with V.A.C..RTM..
The foregoing has outlined some of the more pertinent objects of
the present invention. These objects should be construed to be
merely illustrative of some of the more prominent features and
applications of the invention. Many other beneficial results can be
attained by applying the disclosed invention in a different manner
or by modifying the invention as will be described. Accordingly,
other objects and a fuller understanding of the invention may be
had by referring to the following Detailed Description of the
Invention, which includes the preferred embodiment
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features and advantages of the invention will now
be described with reference to the drawings of certain preferred
embodiments, which are intended to illustrate and not to limit the
invention, and wherein like reference numbers refer to like
components, and in which:
FIG. 1 is a block diagram illustrating a closed loop negative
pressure embodiment that operates in accordance with the present
invention.
FIG. 2 is a perspective view of an applicator fastener that
operates in accordance with the present invention.
FIGS. 3 is a perspective view of a V.A.C..RTM. dressing that
operates in accordance with the present invention.
FIG. 4 is block diagram illustrating a closed loop negative
pressure system embodiment, utilizing a V.A.C..RTM. dressing, that
operates in accordance with the present invention.
FIG. 5 is a block diagram illustrating a closed loop positive
pressure system embodiment that operates in accordance with the
present invention.
FIG. 6 is a block diagram illustrating an open loop positive
pressure lavage system embodiment that operates in accordance with
the present invention.
FIG. 7 is a block diagram illustrating an open loop negative
pressure V.A.C..RTM. embodiment that operates in accordance with
the present invention.
FIG. 8 is a block diagram illustrating a combined open loop
negative pressure V.A.C..RTM. and positive pressure pump system
embodiment that operates in accordance with the present
invention.
DETAILED DESCRIPTION
Although those of ordinary skill in the art will readily recognize
many alternative embodiments, especially in light of the
illustrations provided herein, this detailed description is
exemplary of the preferred embodiment of the present invention as
well as alternate embodiments, the scope of which is limited only
by the claims that may be drawn hereto.
The details of the preferred embodiments of the present invention
are graphically and schematically illustrated in the accompanying
drawings. Like elements in the drawings are represented by like
numbers, and any similar elements are represented by like numbers
with a different lower case letter suffix.
The preferred embodiments of the present invention, referred to
throughout by the general reference 10, are intended to treat an
afflicted patient 11, and particularly an afflicted area of the
patient's skin 12, or the area immediately subcutaneous thereto,
which is surrounded by a healthy area 13 of patient 11. As shown in
FIGS. 1-8, the preferred embodiments 10, comprise a liquid storage
means 14, a liquid supply means 15 terminated by ends 27 and 29, a
liquid return means 16 terminated by ends 26, 36, 37, and 28, a
liquid movement means 17, a therapy site liquid applicator means
18, a liquid heating means 19, a liquid temperature measuring means
20, and control means 21 which operatively coact in a manner more
fully described below. The embodiments 10 are capable of creating a
localized therapeutic hyerthermia, localized therapeutic
hypothermia, lavage, irrigation, disinfection, or other therapeutic
effects, either alone, or in conjunction with V.A.C..RTM..
Embodiment 10 may be used with a variety of liquids, in addition to
water, and may provide either localized heating or localized
cooling, in addition to direct contact effects from the liquid such
as disinfection, irrigation, lavage, and so forth. However, to
promote ease of understanding, the further description shall focus
on the hyerthermia delivering embodiment using a liquid which on a
w/w % basis is at least 90% water.
As shown in FIGS. 1, 4, and 5, liquid storage means 14, which most
commonly comprises a reservoir, is operatively connected to both
the liquid supply means 15, and to the liquid return means 16 so as
to both provide liquid to liquid supply means 15 via outlet 22, and
accept liquid from means 16 via inlet 23, as is more fully
described below. Depending upon task dependent design choices,
liquid storage means 14 may either be open, closed, or pressurized,
so long as an adequate supply of liquid covers end 27 of supply
means 15 when the embodiment 10 is in operation.
Control means 21 is connected to both liquid heating means 19 and
liquid temperature measuring means 20 and coacts therewith in a
manner more fully described below. Measuring means 20 may be
located as necessary, depending upon both the speed of liquid flow,
and the degree of temperature loss encountered. In a low speed flow
embodiment, such as in FIG. 7, a location in proximity to end 29
may well be most desirable. Control means 21 receives temperature
information from means 20 and, using this information, continuously
regulates the power to heating means 19 in order to achieve the
desired liquid temperature in a manner that is, at least in
general, well known to those of ordinary skill in the art. Various
control methods, including fuzzy logic, may be used to regulate the
temperature of the liquid. The liquid temperature may be controlled
to within 0.5.degree. C. and possibly to within 0.1.degree. C.
The precision heated liquid is delivered to the afflicted area 12
of patient 11 via liquid supply means 15, therapy site liquid
applicator 18, liquid return means 16, and liquid movement means 17
all of which coact as described more fully below. Liquid movement
means 17 generally comprises a pump of adequate capacity, as is
well known in the art. Although the exact connection configuration
of means 17 depends upon the overall system configuration of
embodiment 10, in the presently preferred embodiment of embodiment
10, shown in FIG. 1, means 17 is operatively connected to liquid
return means 16 via inlet 24 of means 17 and outlet 25 of means 17.
This configuration supplies a negative pressure to applicator 18
because of the liquid it extracts therefrom. This negative pressure
serves to hold applicator 18 in place about afflicted area 12 of
afflicted patient 11 without the need for a separate engagement
means being attached thereto. An alternative embodiment utilizing
negative pressure is also shown in FIG. 7, where the V.A.C..RTM.
dressing adhesive covering 62, schematically represented in FIG. 3
coacts with dressing material 60 to perform the function of
applicator 18, as is also shown in FIG. 8. The V.A.C..RTM.
embodiment would most likely be employed where afflicted cells
comprise an open wound, such as is shown in FIGS. 7 and 8, where
dressing material 60, coacts with dressing adhesive covering 62 to
function as applicator 18 and covers wound 64 and also allows
vacuum generated underneath dressing adhesive covering 62 to drain
wound 64.
Some applications may require avoiding applying negative pressure
to the afflicted area 12, by applying positive pressure as shown in
FIGS. 5 and 6, thus alternate configurations could be used, such as
shown in FIG. 2, where fastener 50 is depicted; plainly such
fasteners are well known in the art, and any such known suitable
fastener could be employed. The use of separate engagement means,
such as fastener 50, to hold applicator 18 in place would avoid the
need to apply negative pressure to afflicted area 12.
As shown in FIGS. 1, 4, 5, 6, and 8, a variety of alternate
configurations of liquid movement means 17 could be used including
configurations which would place means 17 at various positions
along either liquid supply means 15, as shown in FIGS. 5 and 6, or
liquid return means 16, as shown in FIGS. 1 and 4. In FIG. 7,
negative pressure collection container 66 is used in lieu of liquid
movement means 17 to move the fluid. As previously stated, the
device in FIGS. 5 and 6 would require the use of fastener 50,
whether the afflicted cells 12 were on the skin, or subcutaneous
thereto. One alternative configuration (not shown) could place
liquid movement means 17 inside reservoir 14 in a manner that would
connect outlet 25 of liquid movement means 17 connected to end 27
of supply means 15. Alternatively, liquid movement means 17 could
be placed inside reservoir 14 with inlet 24 of liquid movement
means 17 connected to end 28 of return means 16. Alternative
configurations, which would place liquid movement means 17 inside
applicator 18, could also be used. Fastener 50 would be required if
a positive pressure embodiment is employed.
Returning now to the specific embodiment shown in FIG. 1, liquid
supply means 15 comprises supply end 27, delivery end 29, and a
body portion intermediate these two ends. Applicator 18 comprises
top 30, open bottom 31, outer surface 32, inner surface 33, liquid
supply means receptor 34, and liquid return means receptor 35.
Liquid return means comprise recovery end 26; pump intake end 36,
pump output end 37, reservoir inlet end 28, every part of itself
between end 26 and end 36, and every part of itself between end 37
and end 28. Liquid supply means 15, applicator 18, liquid return
means 16, reservoir 14, and liquid movement/pressurization means 17
interconnect and coact in the following manner.
Supply end 27 of liquid supply means 15 is placed in liquid tight
operative engagement with outlet 22 of reservoir 14. Delivery end
29 of liquid supply means 15 is placed in fluid tight engagement
with applicator 18 via liquid supply means receptor 34 thereof.
Applicator 18 is arranged about afflicted area 12 so that the inner
surface 33 of open bottom 31 surrounds area 12, and most likely
area 13, in fluid tight engagement. Cavity 38 is defined by inner
surface 33, afflicted area 12, and the portion of area 13
surrounded by open bottom 31, as described above.
In this configuration pump 17 is placed between end 36 of liquid
return line 16 and end 37 of liquid return line 16 in the following
manner. End 26 of liquid return line 16 is placed in fluid tight
engagement with liquid return means receptor 35. Pump intake end 36
of liquid return line 16 is placed in fluid tight engagement with
pump intake 24. Any desired filtration means (not shown) could also
logically be placed in proximity thereto. Pump output end 37 of
liquid return means 16 is placed in fluid tight engagement with
outlet 25 of pump 17. Reservoir inlet end 28 of liquid return means
16 is placed in fluid tight engagement with inlet 23 of reservoir
14.
The system control means regulate the overall operation of the
embodiment 10, in a manner well known to those skilled in the art.
Actuation means, timing means, data collection means, data
recordation means, alarm means, and emergency shutoff means (all
not shown) are just a few of the possible functions which could
comprise the functions carried out by system control means.
Existing data processing means remote from the location of the
embodiment 10 could well perform some of these functions.
The embodiment 10 would be used in the following manner. The
embodiment is connected to a power source (not shown) in reasonable
proximity to the afflicted patient 11, convenient for attachment
about afflicted area 12. If necessary, the control means are
activated. A selected temperature is entered into set point
controller 21. If desired, a selected duration is entered into the
optional timing means. Any temperature or other alarm values are
also entered into the system control means. Applicator 18 is placed
about afflicted area 12. Embodiment 10 is activated. When the
temperature of the liquid in reservoir 14 approximates the selected
temperature set into controller 21, pump 17 is enabled. Upon
actuation, pump 17 first partially evacuates cavity 38, thereby
creating a negative pressure differential. This negative pressure
acts to hold applicator 18 in place about afflicted area 12. Heated
liquid then exists reservoir 14 through outlet end 27 of liquid
supply means 15, and passes through supply conduit liquid supply
means 15, enters applicator 18, comes into contact with afflicted
area 12, transfers heat to afflicted area 12, and exits applicator
18 into liquid return means 16. This liquid passes through the pump
17 and is returned into reservoir 14 through inlet end 28 of liquid
return means 16, thereby completing the loop.
Certain advantages may accrue from moving the heated liquid rapidly
through the embodiment. These advantages are believed to include
better temperature control, a faster rate of heat transfer to the
afflicted cells, a quicker attainment of thermal equilibrium, and a
lower requirement for total system liquid. It is also anticipated
that this device and modality would also be effective in treating
cells subcutaneous the skin areas 12 and 13, placed within the open
bottom 31 of applicator 18.
Additionally, an open loop system, as shown in FIG. 6, where fluid
comes into contact with skin areas 12, 13, and is then either
discarded, in a manner well known in the art, or is placed in
storage for later disposal, in a manner well known in the art,
could be used for irrigation therapy, lavage, or the like. As is
apparent to one of ordinary skill in the art, this apparatus would
well serve this purpose if an open loop system were to be used, and
a positive, rather than a negative pressure pump is provided. In
that case, an additional mechanism to hold applicator 18 in place,
fastener 50, would be required, as the pump would be operatively
connected with liquid supply means 15 rather than liquid return
means 16. Fluid supply means would supply either a limited quantity
of fluid, such as from reservoir 14, or an unlimited source of
fluid from a faucet or the like.
An additional embodiment would be to use a mild oxidizing agent as
the fluid in this device. Such an agent, were it to have a greater
affect upon afflicted cells, than non-afflicted cells, would
provide an enhanced therapeutic effect in conjunction with the
therapy herein described. An example of such a solution would be 3%
Hydrogen peroxide, U.S.P. Likely a more benign disinfecting
solution would be used, such as are well known to those skilled in
the art, for irrigation or other treatment of wounds.
While the invention has been described herein with reference to
certain preferred embodiments, theses embodiments have been
presented by way of example only, and not to limit the scope of the
invention. Many other variations are possible, which would be
obvious to one skilled in the art. Accordingly, the scope of the
invention should be identified only in accordance with the claims
that follow.
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